Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. is continuing his battle to remake federal vaccine policy, this time by rewriting the charter of a federal committee that wields enormous influence over childhood immunizations to shift its focus beyond vaccines.
During his confirmation hearing, Kennedy promised senators that he would not alter the Advisory Committee on Immunization Practices (ACIP), which makes vaccine recommendations to the Centers for Disease Control and Prevention (CDC), including which vaccines should be available for free to needy children and which ones should be covered without a copay by private insurance.
Within a few months of taking office, however, Kennedy, a long-time anti-vaccine activist, fired all 17 members of the committee, replacing them with people who have cast doubt on vaccine safety.
Kennedy, who has made millions of dollars working with attorneys suing a vaccine manufacturer, took a hatchet to the childhood immunization schedule in January, slashing the number of recommended vaccines from 17 to 11.
US District Court Judge Brian Murphy paused Kennedy’s assault on vaccine access in March, when he said the Trump administration violated federal law by making vaccine policy changes that were “arbitrary and capricious.”
In his ruling, Murphy also found that 13 of Kennedy’s hand-chosen appointees to ACIP “appear distinctly unqualified,” which led the CDC to cancel all of the group’s scheduled meetings. The judge’s ruling came in response to a lawsuit by the American Academy of Pediatrics (AAP) and other medical groups.
ACIP became ‘ideological mess’
Kennedy “stacked ACIP with unqualified people, and it just became this ideological mess,” said Peter Hotez, MD, codirector of the Texas Children’s Hospital Center for Vaccine Development.
The revamped ACIP “doesn’t seem to be able to identify and evaluate evidence in any type of organized fashion,” said Kevin Ault, a professor of obstetrics and gynecology at the Western Michigan University Homer Stryker School of Medicine.
Instead of considering the dozens of studies on the birth dose of hepatitis B vaccines, the ACIP last year focused on a single study that confirmed Kennedy’s view that the shot isn’t safe, said Ault, a former ACIP member. The committee then voted to replace the universal hepatitis B vaccine birth-dose recommendation with shared clinical decision-making for infants born to mothers who test negative for the virus.
Richard Hughes IV, the attorney representing AAP, said the revised ACIP charter is “just an attempt to make things look better on paper,” adding that the charter “does not cure the problems we are challenging.”
The old charter required real expertise in vaccine use, vaccine research, or vaccine safety and efficacy
In a statement, HHS spokeswoman Emily Hilliard wrote, “The updated ACIP charter clarifies the committee’s advisory role and responsibilities to improve transparency, accountability, and efficiency, while preserving its longstanding mission to review scientific evidence and make recommendations on vaccines and immunization practices.”
Redefining committee members’ qualifications
The new charter, posted online yesterday, shifts the committee’s focus from reviewing and recommending vaccines to considering other ways to prevent disease. It also redefines the qualifications required to join the committee in ways that would allow Kennedy’s appointees to continue to serve.
Instead of requiring members to be experts on vaccines, the new charter states only that “members shall collectively represent a balanced range of scientific, clinical, and public health expertise relevant to the committee’s mission.”
That language makes it easier for Kennedy to pack ACIP with anti-vaccine activists, rather than scientists with expertise in vaccine science, said Jake Scott, MD, a clinical associate professor of infectious diseases and geographic medicine at the Stanford University School of Medicine.
“The old charter required real expertise in vaccine use, vaccine research, or vaccine safety and efficacy,” said Scott, who writes occasional columns for CIDRAP News.
The new requirements for members are “broad enough to seat almost anyone with a health-adjacent title,” Scott said. “It is hard to read it as anything other than retrofitting the rules to fit the people who failed them.”
Scott said the new charter rewrites the ACIP’s job description.
“The old assignment was to figure out how to use vaccines well,” Scott said. “The new one, in plain terms, is to build the case against them.”
Providing vaccinations to needy children
One of ACIP’s most important responsibilities is to recommend which immunizations should be covered by the Vaccines for Children (VFC) program, a federal initiative that provides free vaccinations to needy children. About 40 million children are eligible for this program. The new charter changes the language about this program.
“There seems to be a loosening of the relationship between ACIP recommendations and coverage by the Vaccines for Children program,” said Paul Offit, MD, director of the Children’s Hospital of Philadelphia Vaccine Education Center.
If ACIP votes to exclude a vaccine from the VFC, more than half of US kids would lose access to that immunization, said Offit, a former member of ACIP. That could deprive children of lifesaving vaccinations without an explicit ban.
The old assignment was to figure out how to use vaccines well. The new one, in plain terms, is to build the case against them.
If ACIP appointees are told to consider only the risks of vaccines, rather than also considering their benefits, “you have built a body designed to recommend fewer of them,” Scott said. “Fewer recommendations mean narrower coverage, and the families with the least cushion feel it first.”
‘Confusion and delays’ that threaten public health
The new charter will “lead to confusion and delays that threaten public access to lifesaving vaccines and evidence-based, accurate information,” according to a joint statement from the Infectious Diseases Society of America (IDSA), the Pediatric Infectious Diseases Society, the Society for Healthcare Epidemiology of America, and the Society of Infectious Diseases Pharmacists.
“In this new charter, governance of the committee would be the responsibility of the CDC director instead of members with deep expertise on immunization, which would intensify politicization of the ACIP,” the societies wrote. “The new charter inappropriately emphasizes potential gaps or limitations in vaccine data, which could be used to delay, rescind or refuse to make evidence-based vaccine recommendations.”
ACIP’s former charter committed the group to holding three public meetings a year. But the new charter states only that “meetings will be held at the discretion of the ACIP designated federal officer in consultation with the chair and will be open to the public except as determined otherwise by the CDC director.”
The CDC currently lacks a permanent director. Jay Bhattacharya, MD, the director of the National Institutes of Health, is serving as acting director.
Among other changes, the new charter revises the list of medical societies serving as technical advisors to ACIP. In the past, these non-voting liaison members included well-known, highly respected medical associations, such as the AAP, the IDSA, and the American College of Obstetricians and Gynecologists.
Now, the ACIP will also be advised by four little-known groups with a history of anti-vaccine statements, including the Association of American Physicians and Surgeons, Independent Medical Alliance, and Physicians for Informed Consent.
“What [Kennedy] is doing is incredibly dangerous,” said Offit. “I just feel like we’re slowly approaching this cliff and about to fall off in slow motion.”